JCIA 4th Edition

FMS.2 and FMS.8-8.2 MEDICAL EQUIPEMENT MANAGEMENT PLAN √ If Present

– OUTLINE

 Purpose
o To establish a plan for inspecting, testing, and maintaining medical
equipment and documenting the results

 Risk Assessment process

o Based upon manufacturer’s guidelines and historical data or other process
that is defined in policy/plan
 Risk assessment relates to risk to patient if the equipment failed or
functioning was disrupted

 Program strategies
o Describe process for identifying and listing all medical equipment in the
organization
o Process for inspection of medical equipment at time of purchase
o Describe prevention maintenance program
 Including laboratory and radiology equipment and equipment
maintained by a vendor
 State how the vendor repairs and preventive maintenance
data are integrated with the medical equipment
management program
 Statement that if equipment maintained by vendor contract, copies
of testing are provided to biomedical engineering
o Establish and maintain a repair program
 Keep historical repair record
 Establish criteria for prioritizing work processing of repair
 Describe process for addressing user error rather than malfunction
of the equipment
 Use repair data for planning and improvement purposes
o Establish a product recall system
 Policy addresses use of equipment (e.g., withdrawing from
services) after recall
o Reference policies and procedures and country regulations to support
medical equipment management plan

 Training / education program

o Staff training in use of equipment
o Medical equipment maintenance staff training

 Monitoring data (measures) for improvements in the safety and security

program
o Define monitoring measures
o Define collection, aggregation, report structure, reporting process and
frequency (according to schedule)
o Integration of data and analysis into Safety Committee

JCI Medical Equipment Plan – Outline

P. 1
 JCIA 4th Edition

FMS.2 and FMS.8-8.2 MEDICAL EQUIPEMENT MANAGEMENT PLAN √ If Present

– OUTLINE
 Annual program plan evaluation
o Statement describing the process for the annual evaluation including
use of preventive maintenance records, repair records for malfunctions,
performance monitoring data, staff training findings, new equipment
purchase or planned to be purchased, review of program goals, and
recommendations for program or policy and training changes.

JCI Medical Equipment Plan – Outline

P. 2